Senior Regulatory Affairs Officer
Watford, Hertfordshire, United Kingdom
Job Description
Senior Regulatory Affairs Officer
Watford UK - Hybrid
Senior Regulatory Affairs Officer opportunity working for an established pharmaceutical company that specialise in generic, OTC, and prescription medicines. The business is increasingly growing and is looking for a personable and detailed oriented professional to join the small team and support with a number of RA activities.
As a Senior Regulatory Officer, you will be responsible for managing regulatory submissions and variations applications for a range of different generic products.
Responsibilities
- Take responsibility for post-approval activities including, variations (type 1a, 1b, and type 2), renewals, license changes, and CMC change controls.
- Preparation, of new MAA in the UK and Europe and support with any new registration applications.
- Supporting labelling and artwork changes (SmPc, PIL, and mock-ups)
- Preparation, submission, and management of approvals of National, MRP, DCP, and CP applications in the UK and European region.
- Registration of medicinal products into Non-EU countries
- Bachelor\'s degree or higher in Life Sciences or technical field.
- 18 months to 2 years of relevant regulatory experience.
- A strong communicator who is able to navigate through difficult conversations with senior stakeholders.
- Previous EU market experience with strong experience submitting through MRP, DCP and national procedures.
To apply for this role you must have the full right to work in the UK as this employer does not provide sponsorship. For more information please contact
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Job Detail
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Job IdJD2992926
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationWatford, Hertfordshire, United Kingdom
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EducationNot mentioned